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Since the introduction of the report states these were recommendations and had not been officially implemented, we would have to know if any 510k's would be grandfathered in under old rules or whether anything "in-process" would be subject to new rules.
On the other hand, you have to set your expectations to what the show allows.
1. You can't see a demonstration of the device.
2. You won't see any materials that were not included as part of the 510k (if SE is not granted by the show)
So what you will see is Mike, Dean, the shell, and the static marketing materials as they were when the 510k process started (or as of the April 5th resubmission). I3 may also choose to omit details that could give a competitor ideas on your secret sauce.
If you are the competition, you are there to talk about your device, not whether you are scared of the competition. So you put your poker face on, talk up your device, and if someone asks "What about Bob over there?" you nod your head a little and say "Bob's got a nice product." and end the conversation. Doesn't matter if it's a legitimate threat to your market or not.
Now if they have approval prior to RSNA, it's a whole different ballgame of course.
I get tired of posting this, but nobody seems to pay attention.
This was Mike's repsonse to me when I asked about the information sent July 5th.
"What Dean sent the FDA was on his own initiative not at the request of the FDA for a formal resubmission like we had to do for the new review team in April. My understanding – and if my understanding is off-base in any way I’ll let you know – is that Dean annotated the document so that the reviewer could connect the dots faster. The prior review team had asked for some non-standard things (for lack of a better phrase) and these requests from Team #1 complicated things for Team #2. It was just easier for Dean to expand the table of contents with more specific information and then tag those sections in the document. This would be best accomplished by simply giving them another copy of the full document with annotations and other explanatory text to help this reviewer understand the structure of the document which has become very large."
The 510k number is not made public until an SE decision is made.
Considering it took the new FDA team 183 days to issue an SE for an x-ray machine, I certainly wouldn't put it past them.
Given incompetence is systemic at most govt. agencies and big guys spend hundreds of thousands if not miillions on lobbyist, I'd be more inclined to believe we are simply stuck in the government paperwork bureacracy. Second choice would be some behind-the-scenes activity by a big player.
Third choice would be I3 is vaporware. If this was really all a scam, Dean would have cashed out long ago and instructed family and friends to do the same. It does not appear that has happened aside from the typical profit taking when it hit 1.95.
In addition, since the DVIS uses off-shelf-parts for its detectors, arrays, etc. it should match the minimum of what's out there now.
I could be mistaken, but until there is a decision, I don't believe the application number is revealed.
Hi Joe,
As it pertains to #4, NEPH ey got an NSE very late in the game and it would be good to know why since they are the outlier as far as long-term NSE results go.
I put this spreadsheet together to keep track of share-price vs. buyout price.
Share Buyout
2.7 1,014,522,810.30
2.8 1,052,097,729.20
2.9 1,089,672,648.10
3 1,127,247,567.00
3.1 1,164,822,485.90
3.2 1,202,397,404.80
3.3 1,239,972,323.70
3.4 1,277,547,242.60
3.5 1,315,122,161.50
3.6 1,352,697,080.40
3.7 1,390,271,999.30
3.8 1,427,846,918.20
3.9 1,465,421,837.10
4 1,502,996,756.00
5 1,878,745,945.00
6 2,254,495,134.00
7 2,630,244,323.00
8 3,005,993,512.00
9 3,381,742,701.00
10 3,757,491,890.00
The PPS moving sideways the last week was evaporating?
I'm implying when you are beholden to the government, it is not in your best interest to disparage them publically no matter how you feel about them privately or what the reality of their behavior is.
As for not saying anything, if someone asks the question publically "How is that FDA review team?" silence is just as bad as a negative response.
If you are trying to get something through the government, you won't say anything negative about them until it is absolutely safe to say so/past the point of no return. Until then, everything is "Yes sir, may I have another."
Dean saying "The FDA is always professional, this review team is better than the old one." is like saying "Yeah, the people who have a rocket launcher pointed at me are swell!"
Also remember from IS_Guru's research and VKNG's recent approval, there can be significant lag between the decision date and notification date. Until an actual 510k approval letter shows up, we will have no idea what date the approval was actually made.
I believe in a conference call earlier in the summer, Dean stated that the state of California requires you to put a date (any date) on your proxy materials so they can approve them, and then, if necessary, change the date.
It is also reasonable to assume that I3 made a decision while interacting with the old review team to suspend beta plans because of the impact it would have on the 510k.
I don't expect management to give me a blow-by-blow of every decision they've ever made. Maybe someone should ask Mike "What caused the change in the beta/luminary test site plans from 2007/2008?"
I sure get tired of posting this. I asked Mike, after the news of the July 5th document, specifically if it would count as a new submission. This was the response.
"What Dean sent the FDA was on his own initiative not at the request of the FDA for a formal resubmission like we had to do for the new review team in April. My understanding – and if my understanding is off-base in any way I’ll let you know – is that Dean annotated the document so that the reviewer could connect the dots faster. The prior review team had asked for some non-standard things (for lack of a better phrase) and these requests from Team #1 complicated things for Team #2. It was just easier for Dean to expand the table of contents with more specific information and then tag those sections in the document. This would be best accomplished by simply giving them another copy of the full document with annotations and other explanatory text to help this reviewer understand the structure of the document which has become very large."
What do you derive the October 20th date you keep posting about from?
I wonder if being in Korea was one reason the 510k with the xray machine took so long?
The incompetence inside governmental organizations is astounding, I assure you.
Not that there can't have been mistakes made by I3, but to say this is all his fault is stretching it a bit, I think,
Just wondering what your thoughts are on why the 4-5 cent spread has stayed relatively constant this morning? I'm used to seeing them much closer and changing much faster.
Thanks very much IS. I tried and abandoned such a project many months ago.
I've often thought of writing a URL crawler that could hit the website where all the images of the approval letters go (since the numbers are sequential) and just return new ones each day.
However, that would look like hacking to the webserver/firewall/IDS, etc. and not a risk that's worth taking, imho.
It was not a re-submission and more of a clarification. Here is what Mike N. sent me in response to that:
"What Dean sent the FDA was on his own initiative not at the request of the FDA for a formal resubmission like we had to do for the new review team in April. My understanding – and if my understanding is off-base in any way I’ll let you know – is that Dean annotated the document so that the reviewer could connect the dots faster. The prior review team had asked for some non-standard things (for lack of a better phrase) and these requests from Team #1 complicated things for Team #2. It was just easier for Dean to expand the table of contents with more specific information and then tag those sections in the document. This would be best accomplished by simply giving them another copy of the full document with annotations and other explanatory text to help this reviewer understand the structure of the document which has become very large."
If I am not mistaken, their device is not a radiation emitting device. It is a camera system. Not sure they are even in the same ballpark as IMGG.
Can you provide a link or name of the credible biotech web consultant?
Something like that, while it might be satisfying, would certainly rock the boat with the people who hold the life of your company in their hands.
Since IMGG sent in their re-submission in April, what makes you think the 150 day rule is not in effect? April is the beginning of the 2nd quarter and the reported results show 1st and 2nd quarter decisions 100% within 150 days. Unless I am missing something.
I agree. Given they are a government agency and therefore not subject to any real performance measurements, a few days is acceptable.
If they are anything like most government agencies the lag time between decision making and decision notification could easily be 3-5 days.
The numbers after the year appear to be sequential. For example, if you go to the FDA recently approved devices and pick one of the linked notices, you can increase the number after the year and hit other notices that generally have submission/receival times after the one you started with.
Every so often though, there's an oddball so who knows.
Which part of "completely new review team" at the beginning of the year do you not understand?
Bust has posted numerous times why the process essentially restarted with the new review team. Start counting from them and we haven't been it a year yet.
And if you look at the old team, there's a reason they and the CDRH head were all canned.
And when Google came out, people were going "Oh, a search engine...how quaint. It's good and all, but it's not Yahoo or AltaVista or Metacrawler."
History is full of examples where incumbent players didn't demonstrate interest in up and comer's with disruptive innovation until something pivotal happened and then they either bought out the company, licensed the technology, or let it go and the up and comer matured like Google.
Not to mention we went through all the "increase in authorized shares" stuff when the material first came to light in July.
First, only 375 out of the current 500 million authorized shares have been issued.
Second, the increasing of authorized shares does not mean they will be automatically issued.
Third, this is a common tactic used to prevent hostile take over, a poison pill.
I don't know how you have the willpower to go on with this board, Bust. Might as well setup an auto-responder with 5 or 10 options on it and just set it to post every 30 minutes.
I'm a fan of the phrase "cautiously optimistic"
I'm a fan of the phrase "cautiously optimistic"
Wouldn't it be a little more fair to count from the removal and replacement of the review team?
I don't know if you've ever worked for a government agency, but a team change typically means you have start all over so the incompetence of your predecessor doesn't land you in hot water.
And so because the point being made by an extremely bright software engineer, who shall remain nameless/anonymous and whose qualifications we cannot verify, is that it will be "very challenging and next to impossible to achieve", that's the final word on the subject?
I'm sure people like the Wright Brothers, Tesla, and Watson/Crick would have something to say to your software engineer.
I'm on a trip right now, but if you dig back in my posts, you'll find one where I included an e-mail from Mike stating that the clock did not stop.
Maybe its just me, but if this task was impossible with the design IMGG is using, wouldn't we have heard about it from the medical community long before now. Shouldn't their be a whole rash of people from previous RSNA's who looked at the device and said "BS-you can't make this work and here's why...". I mean, the patents has been available, it's been at RSNA's, it clearly produced some kind of test images for the radiologists to review.
Instead all we have is a photoshop anaylsis from a guy on a message board. Not terribly convincing.
Which of the devices you listed are in the same marketplace as the DVIS?
Number 1: Cardiac imaging only
Number 2: Cardiac imaging only, no quantitative definition of "real-time"
Number 3: Cardiac imaging only, ultrasound technology
Number 4: Cardiac imaging only, appears to require the magnetic particle agent
So that's 4 cardiac only devices, none of which use wall power, none of which can fit through a standard doorway, and none of them with the breadth of functionality as the DVIS.
Seems like apples and oranges to me.
It's hard to tell from the video, but it looks like the Medtronic would not fit through a stand doorway nor does it use regular 110ac. Both are things that seperate the DVIS from the competition in addition to the Medtronic not doing real-time.